510(k) K943516 ยท KFF Assay, Heparin
ROTACHROM HBPM/LMWH TEST KIT
| Applicant | American Bioproducts Co., Parisppany NJ, US |
| Decision | Substantially Equivalent, Aug 31, 1995 |
| Received | Jul 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943516
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.